Label: EQUATE OMEPRAZOLE- omeprazole tablet, orally disintegrating, delayed release
- NDC Code(s): 49035-392-55
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated May 28, 2019
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- Active ingredient (in each tablet)
Do not use if you have:
- trouble or pain swallowing food, vomiting with blood, or bloody or black stools
- heartburn with lightheadedness, sweating or dizziness
- chest or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequent chest pain
These may be signs of a serious condition. See your doctor.
- Ask a doctor before use if you have:
- Ask a doctor or pharmacist before use if you are
- Stop use and ask a doctor if:
- If pregnant or breast-feeding,
- Keep out of reach of children.
- for adults 18 years of age and older
- this product is to be used once a day (every 24 hours), every day for 14 days
- it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours
14-Day Course of Treatment
- take 1 tablet before eating in the morning
- do not crush or chew tablets
- place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
- take every day for 14 days
- do not take more than 1 tablet a day
- do not use for more than 14 days unless directed by your doctor
- do not take this medicine with alcohol
Repeated 14-Day Course (if needed)
- you may repeat a 14-day course every 4 months
- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
- children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
- Other information
amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone, ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate
- Questions or comments?
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
omeprazole tablet, orally disintegrating, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-392 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH) ASCORBIC ACID (UNII: PQ6CK8PD0R) CETYL ALCOHOL (UNII: 936JST6JCN) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSES (UNII: 3NXW29V3WO) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM STEARATE (UNII: QU7E2XA9TG) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color RED (reddish) Score no score Shape ROUND Size 9mm Flavor STRAWBERRY Imprint Code 20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-392-55 3 in 1 CARTON 02/23/2018 1 14 in 1 CARTON 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA209400 02/23/2018 Labeler - Wal-Mart Stores Inc (051957769)